The nation's leading producer of intravenous (IV) bags, Baxter International Inc., today announced a commitment to develop alternatives to and phase out polyvinyl chloride, or PVC, for their products, beginning with IV bags.

More than 500 million IV bags are used in the United States every year to deliver blood, medication and other essential fluids to sick and injured patients.  Eighty percent of these are made of PVC.  These vinyl IV bags have been shown to leach the toxic chemical di-ethylhexyl phlthalates (DEHP) into the solutions they contain.

The announcement comes in the wake of mounting public pressure to eliminate patients' needless exposure to dangerous chemicals, such as DEHP, when safe, cost-competitive alternatives exist.  The company negotiated with public health advocates from Health Care Without Harm (HCWH), an international campaign of 41 hospitals and more than 130 other health and environmental organizations, and stockholders affiliated with the Interfaith Center on Corporate Responsibility, a faith based North American coalition.

The health risks associated with vinyl IV bags recently garnered international attention when HCWH launched a highly visible public education campaign around this issue.

Plastic PVC products require a softener to make them flexible, which is why they are manufactured with DEHP.  DEHP, shown to leach out of the vinyl IV bags, has been classified by the EPA as a probable human carcinogen. Studies have shown that DEHP can damage the heart, liver, testes and kidneys, and interfere with sperm production.

"The medical ethic is 'first, do no harm,'" said Charlotte Brody, R.N. and Co-Coordinator of HCWH.  "We applaud Baxter's decision to reduce the risk of harm by removing PVC from IV bags."

In addition to disclosing the susceptibility of patients to DEHP exposure, the coalition noted that vinyl IV bags also have a high chlorine content. Consequently, vinyl manufacturing and disposal by incineration create dioxin -- one of the world's most toxic chemicals.

"I welcome Baxter's initiative and plan on watching closely how it develops in practice over the next several years," said Dr. Peter Orris, Adjunct Professor of Environmental and Occupational Health Sciences at the University of Illinois School of Public Health.  Dr. Orris represents the Great Lakes Center of HCWH.

In their announcement, Baxter did not specify when the phasing out process would be completed.

The potential dangers of PVC products may be news to the general public, but it's not to some in the medical community.

In fact, certain medications, including the chemotherapy drugs Taxol and Taxotere, come with warnings against using PVC equipment for their administration.  In addition, Abbott Laboratories, another large manufacturer of PVC IV bags, warn that these products have not been tested for carcinogenicity, mutagenicity or fertility effects, and that children and nursing mothers should be particularly cautious when using the product.

Alternatives to vinyl plastics are increasingly being used in Europe, particularly in Austria and Germany.  (Baxter recently purchased Bieffe, a Swiss maker of non-PVC IV products.)

Baxter's decision to phase out PVC IV bags came despite attempts by chemical trade associations to refute claims that these devices needlessly expose patients to toxic chemicals.

Their claims, however, are largely unsubstantiated.  For example:

CLAIM:  Substitutes for vinyl are untested.

FACT:   Twenty percent of the IV market in the U.S. already uses cost-competitive, FDA-approved non-vinyl IV bags.

CLAIM:  The Consumer Product Safety Commission exonerated DEHP.

FACT:   The agency asked the toy industry to remove DEHP from teething  toys in 1986, due to concerns about its toxicity and its ability to leach into children's mouths.

CLAIM:  There is no scientific evidence of risk to humans from DEHP exposure.

FACT:   Damaging effects of DEHP have been demonstrated in peer-reviewed studies of dialysis patients, as well as in animal studies that are designed to gauge safety or risk to humans. DEHP has also beenfound in the blood, brain and liver of premature infants who received respiratory therapy through PVC tubing.

Chlorine and vinyl industry associations also claim that the quality of health care will decline if vinyl medical products are replaced.  To the contrary, HCWH contends that eliminating needless exposures to DEHP and dioxin actually improves public health, without increasing costs.

Health Care Without Harm has more than 170 member organizations, including 41 hospitals, such as Beth Israel Medical Center, New York; New England Medical Center; and the hospitals of Catholic Health Care West.  Other members include the American Nurses Association, Oncology Nursing Society, American Public Health Association, Breast Cancer Fund, Endometriosis Association, Greenpeace, the Sierra Club and many other environmental and social action organizations.

SOURCE  Health Care Without Harm

CO:  Health Care Without Harm; Baxter International Inc.

ST:  District of Columbia

IN:  HEA MTC

SU:

04/06/99 16:57 EDT http://www.prnewswire.com

 Thanks for this to:Toxic Discovery Network, Inc.
                           1906 Grant Ln.
                           Columbia,MO. 65203

Author: Pulec JL
Address:  Pulec Ear Clinic, Ear International, Los Angeles, California 90017, USA.
Source:  Ear Nose Throat J, 77(8):614-6, 619-20, 622, passim 1998 Aug

Abstract:
During the period from 1964 through 1994, the endolymphatic subarachnoid shunt operation was initially successful  in eliminating endolymphatic hydrops and the symptoms and findings it produces in 76% of 645 ears of patients with Meniere's disease. After initial success, lasting from five weeks to nine years, endolymphatic hydrops suddenly returned due to obstruction of the Silastic shunt tube in 11% of patients. In these cases, prompt revision can often restore an initial good result. Histologic and immunologic examination of the material surrounding and occluding the tubes showed an allergic response to the Silastic material in most instances. Efforts to eliminate this cause of failure using a tube of new design and different plastic material are described.

Language
     Eng
Unique Identifier
     98417699
 
 

MESH Headings
     Adult ; Case Report ; Endolymphatic Hydrops SU ; Endolymphatic Shunt *IS ; Equipment Design ; Human ;
     Hypersensitivity *ET ; Male ; Meniere's Disease *SU ; Postoperative Complications ; Reoperation ; Silicone
     Elastomers *AE ; Subarachnoid Space ; Support, Non-U.S. Gov't
 
 

Publication Type
     JOURNAL ARTICLE
ISSN
     0145-5613
Country of Publication
     UNITED STATES
CAS Registry Number
     0 (Silicone Elastomers)

Author: Brownlee JD; Brodkey JS; Schaefer IK
Address: Department of Surgery, Columbia Saint Luke's Medical Center, Cleveland, OH 44104, USA.
Source: Surg Neurol, 49(1):21-4 1998 Jan

Abstract BACKGROUND: A case of colonic perforation by a ventriculoperitoneal shunt is presented in a patient with several previous complications associated with shunt tubing.

CASE DESCRIPTION: Initially managed by intravenous antibiotics, shunt externalization, and colonoscopy, the entire ventriculoperitoneal shunt system was subsequently replaced after cerebrospinal fluid cultures had grown Propionibacterium acnes and Streptococcus sanguis organisms. The patient has had three episodes of skin breakdown over his shunt tubing (two prior and one subsequent to colonic perforation) without evidence of shunt infection or malfunction.

CONCLUSIONS: The etiology of these complications is consistent with silicone tubing allergy. Replacement with a polyurethane system produced no similar complications thus far, which further supports a possible silicone allergy to the ventriculoperitoneal shunt and possible etiology of this patient's colonic perforation.

Language
Eng
Unique Identifier
98090564
 
 

MESH Headings
Adult ; Case Report ; Colon *IN ; Human ; Hypersensitivity *IM ; Intestinal Perforation *ET/IM/RA ; Male ;
Silicones *AE ; Tomography, X-Ray Computed ; Ventriculoperitoneal Shunt *AE
 
 

Publication Type
JOURNAL ARTICLE
ISSN
0090-3019
Country of Publication
UNITED STATES
CAS Registry Number
0 (Silicones)

Prolastic Sheeting is contraindicated for use on patients who have, or are at risk to develop, one
or more of the following disorders: autoimmune diseases; any debilitating disease or infection; lack
of sufficient skin covering; or any disease which puts the patient at risk for surgery.

Pillar Surgical relies on the surgeon, hospital and or clinic that utilize this product to advise the patient of all complications and risks of both the implanted sheeting and the surgical procedures involved.
Complications associated with all surgical procedures should be discussed with the patient such as: infection, poor reaction to the medications and surgical procedures, poor wound poor wound healing, seroma/hematoma, serious fluid build up,nerve damage, nerve serious fluid build up, nerve damage, nerve irritation, neuralgia. loss of sensation, or patient intolerance to any foreign material.

The relationship between silicone elastomer implants and collagen diseases such as Dermatomyositis, Lupus, Erythematosus, Rheumatoid Arthritis, Scleroderma and all other autoimmune phenomena remains
unproven. Patients with collagen autoimmunedisease should not be considered as candidates for silicone implant surgery. The patient must be told that silicone sheeting may cause autoimmune diseases
such as the aforementioned before they consent to surgery for the use of this and other silicone products.

Proper surgical procedures are the responsibility of the surgeon. Each surgeon must evaluate the
suitability of the procedure based upon current accepted techniques, individual judgment, and his or her
surgical training and experience.

To Clean and Sterilize

1. Inspect the sheeting to ensure that it is free of dust, lint, talc or skin oil that may be deposited
during handling. Scrub the sheeting thoroughly with a soft-bristled brush in a hot water soap solution.
Do not use synthetic detergents or oil based soaps, as these may be absorbed and subsequently be leached out to cause tissue reaction.

2. Rinse thoroughly with sterile saline or distilled water.

3. Wrap in a suitable lint free package or place on a clean open tray. Sterilize in a standard
gravity autoclave at 250ƒF (121ƒC) for 30 minutes or 270ƒF (132ƒC) for 15minutes. Or, use
high-speed instrument sterilization or prevacuum sterilization at 270ƒF for 15 minutes.

4. Use of a biological indicator is recommended.

The safety and validation of any sterilization method is the user's responsibility.

ETO (Ethylene Oxide) Gas sterilization is not recommended for silicone elastomers. ETO residuals can cause tissue reactions.

Caution: Pillar Surgical, Inc. relies on the surgeon, hospital and or clinic that utilizes this product
to advise the patient of all complications and risks of both the implanted sheeting and the surgical
procedures involved. Complications associated with all surgical procedures should be discussed with the patient such as: infection, poor reaction to the medications and surgical procedures, poor wound healing, seroma/hematoma, serious fluid build up, nerve damage, nerve irritation, neuralgia. loss of sensation, or patient intolerance to any foreign material. Patients with autoimmune diseases should not be considered as candidates for silicone implant surgery. The patient must be told that silicone sheeting may cause
autoimmune diseases before they consent to surgery for the use of this and other silicone products.

Warranty: Pillar Surgical excludes all warranties, whether expressed or implied by law or otherwise, including but not limited to, any implied warranties of merchantability or fitness of use.Pillar Surgical shall not be liable for any incidental or consequential loss, damage, or expense directly or indirectly arising from the use of this product. Pillar Surgical neither assumes nor authorizes other additional liability or responsibility in connection with this device. Pillar Surgical SOLE responsibility, in the event that Pillar Surgical determines the product defective, when shipped by Pillar Surgical, shall be replacement of the product.

*
Pillar Surgical, Inc

Federal Law restricts this device to sale by or on the order of a physician.

Product Information: Supplied Non-Sterile.

Prolastic Silicone Sheeting is provided in a non-sterile pre-cleaned polyethylene and paper package with a Package
Insert. Size: 6 inches x 8 inches x desired thickness (.005 to .080 inches)
Available R or NR:  Polyester Reinforced and Non-Reinforced (clear)

FDA Registration Information: Pillar Surgical Corporation is FDA compliant and FDA registered as a manufacturer of medical devices. Prolastic Sheeting is registered with the US Food and Drug Administration as a long-term implantable Silicone Sub-Dermal Implant.

Prolastic Sheeting Price List

A silicone subdermal implant *Long Term Implantable

Non-Reinforced

Catalog Number Description List Price

400-05 6" x 8" x .005" (0.127mm) 100.00
400-10 6" x 8" x .010" (0.254mm) 100.00
400-15 6" x 8" x .015" (0.381mm) 110.00
400-20 6" x 8" x .020" (0.508mm) 115.00
400-30 6" x 8" x .030" (0.762mm) 120.00
400-40 6" x 8" x .040" (1.016mm) 130.00
400-50 6" x 8" x .050" (1.270mm) 140.00
400-60 6" x 8" x .060" (1.524mm) 150.00
400-70 6" x 8" x .070" (1.778mm) 150.00
400-80 6" x 8" x .080" (2.032mm) 160.00

Reinforced

Catalog Number Description List Price

401-10 6" x 8" x .010" (0.254mm) 120.00
401-15 6" x 8" x .015" (0.381mm) 125.00
401-20 6" x 8" x .020" (0.508mm) 130.00
401-30 6" x 8" x .030" (0.762mm) 130.00
401-40 6" x 8" x .040" (1.016mm) 160.00
401-50 6" x 8" x .050" (1.270mm) 165.00
401-60 6" x 8" x .060" (1.524mm) 175.00
401-70 6" x 8" x .070" (1.778mm) 180.00
401-80 6" x 8" x .080" (2.032mm) 190.00

Conversion:

8" = 203.3mm
6" = 152.4mm

*Prolastic is certified for long-term implantation.
 

Indications For Use:   Prolastic Sheeting comes in a variety of thicknesses for different surgical applications. For use in a specific application, solely the surgeon, clinic or hospital will determine the employment of Prolastic Sheeting in surgery. Prolastic Sheeting is indicated for the following surgical applications:

Non-reinforced Sheeting Device:

1. Surgical repair of fractured orbital floors; .005"-.010"
2. Surgical Repair of nasal septum and perforated eardrum membrane; .005".
3. For lengthening extraocular muscles in select cases of strabismus; .010"
4. Used in anchoring hemodialysis shunts and other systems; .040"-.060"
5. Various Laboratory uses, including: vial covering, gaskets, stoppers and chromothography;All thicknesses.
6. In surgical instrument applications with retractors and forceps as an instrument covering; All thicknesses

Reinforced Sheeting Device:

1. Used as a protective sheathing to facilitate osteogenesis; .010".
2. For surgical repair of urethral anatomy; .010".
3. To prevent synostosis in completed corrective surgery for cranial fusions and forearm fractures; .010".
4. Lessen soft-tissue fibrosis or bony growths following surgical correction of trismus.
5. For use in fabricating components in artificial hearts and insulating material for electrostimulation devices; .020-.030".
6. As a temporary covering for prenatal rupture omphalocele during staged repair procedures;.010".

To Order, Call

(800) 367-0445 USA/Canada
(619) 525-7908 World Wide
(619) 295-0847 Fax

Author:   Dewan PA; Owen AJ; Ashwood PJ; Terlet J; Byard RW
Address: Urology Unit, Women's and Children's Hospital, North Adelaide, South Australia.
Source: Pediatr Surg Int, 12(1):49-53 1997

Abstract: Migration of particulate matter from plastic tubing and solid plastic implants has been documented in a number of studies, including some with the use of cardiac bypass, haemodialysis, and pump-assisted intravenous infusions. In order to ascertain whether silicone embolisation occurs when children have an Ivac 560 pump-assisted IV infusion,  we passed 180 ml of pumped fluid through a microfilter and compared the scanning electron micrographs of those filters with unused filters and with others through which a similar volume had been passed without using the pump.

The particles on the filters were analysed for their elemental content using energy-dispersive X-ray analysis. In addition, the appearance of the silicone tubing used in the pump over 3 and 72 h was assessed and compared to that of flow-only and unused tubing. More particles were found on the microfilter when fluid had been delivered via the pump than on those through which non-pumped fluid had passed or that were unused. Elemental silicon-containing particles were only found on the filter when a pump had been attached to the IV line. The flow-only and unused tubing were found to have adherent particles on the inner surface that were not seen once the  tubing had been used for 3 h in the Ivac 560 pump. Also, after 72 h use, the silicone tubing had a deformed inner layer. The clinical significance of these findings is yet to be determined, but it does appear that silicone embolisation occurs during pump-assisted infusions in children.

Language
     Eng
Unique Identifier
     97187757
 
 

MESH Headings
     Biocompatible Materials ; Cellulose AA ; Child ; Electron Probe Microanalysis ; Embolism ET ; Filtration ; Foreign
     Bodies ET ; Human ; In Vitro ; Infusion Pumps * ; Infusions, Intravenous *IS ; Membranes, Artificial ; Microscopy,
     Electron, Scanning ; Silicones * ; Time Factors
 
 

Publication Type
     JOURNAL ARTICLE
ISSN
     0179-0358
Country of Publication
     GERMANY
CAS Registry Number
     0 (Biocompatible Materials); 0 (Silicones); 9004-34-6 (Cellulose); 9004-35-7 (acetylcellulose)

From: ilena@san.rr.com (Ilena Rose)                        "Found this whole book fascinating - here's a great excerpt:"
Organization: Humantics Foundation for Women
Newsgroups: alt.support.breast-implant

Chapter Eight - An Overview

"By the 1930s, no one would dream of intentionally putting raw silica into the human body because silica dust had been shown to cause acute illness and death or a chronic lung-damaging disease known as silicosis when the dust was breathed. When silicon dioxide in the form of crystalline silicon is injected into the body, it stimulates a florid inflammatory response. It is so potent an inflammatory agent that many laboratories use it as a "booster" or adjuvant to provoke the most massive immunologic response possible in test animals.

The Food and Drug Administration (FDA) has since found that silicone breast implants were "intentionally adulterated" with silica that was added as a filler in the envelope to change the properties of the silicone in the eslastomer envelope. In the 1940s, Dow Chemical Company acquired the patent rights and gave them to an independent subsidiary formed between Dow Chemical and the Corning Glass Corporation, the Dow-Corning Corporation of Midland, Michigan. (Corning had the most expertise in the world in dealing with silica, the basic ingredient of glass.

Although the original 1966 patent described these implants as being a totally implantable, nonreactive device to be placed within the human body adequate safety testing or formal trials of the new device were never conducted. That is, neither the degree of nonreactivity nor the adequacy of
the containment of the silicone had been established prior to its marketing.
In fact, according to Tom Talcott, the scientist who helped design the first
envelopes, they were "never designed to hold and retain silicone." The slow
oozing of silicone gel from breast prostheses manufactured in the early 1970s is evident to any person who has held them in his hands; they are greasy to touch. Yet the company has maintained that it could not have known that a "bleed problem" existed in their product until after researchers outside their laboratories tested them.

Keith Polmanteer, a Dow Corning's scientist, was granted a mammery
prostheses patent: Patent: #4,138,382, dated February, 1979, which states:
"In the unlikely event of breakage of container 21 or in the event of seepage of gel 22 through container 21 (e.g. by osmosis), the infinitely swellable gel is observed to be absorbed and dissipated by the body. The dissipation of the hydrophilic gel by the body represents an improvement over previously known hydrophobic gels."

Polmanteer's patent also states: "The funnel is about half filled with alumina (obtained from Alcoa)....is then added along with 0.04g. of Vazo 64r (anzobis(isobutyronitrile) free radical catalyst to initiate polymerization, available from DuPont."